Kornimate/medical-research-clean huggingface dataset:
the impact of cigarette smoking on periodontal therapy

Conditions: Periodontitis; Cigarette Smoking

Summary: periodontitis patients, 40 cigarette smokers and 40 non-smokers (defined by cotinine measures in serum), were recruited to this double arm prospective cohort study. data were collected 3 months following non-surgical and surgical periodontal treatment, and following 12 months with supportive periodontal therapy. data collected were clinical attachment level, probing depth, bleeding on probing,oral bacteria, serum, blood (paxgeneblood), and gingival crevicular fluid.

the overall aim of this work was to study clinical outcomes of active and supportive periodontal therapy in smokers and non-smokers with chronic periodontitis at patient, tooth, and site level. moreover, to compare the periopathogenic microflora and inflammatory markers in gingival crevicular fluid and in blood in smokers and non-smokers following therapy. eighty patients, 40 smokers and 40 non-smokers, with moderate to severe chronic periodontitis were included in this prospective cohort study and treated non-surgically and surgically, and then followed-up in a supportive periodontal therapy program for 12 months. smoking status was validated measuring serum cotinine levels at pre-treatment and 12 months following supportive periodontal therapy. clinical measurements included full mouth recordings of clinical attachment level, probing depth, bleeding on probing, and plaque index at pre-treatment and following active and supportive periodontal therapy. at the same timepoints, subgingival plaque samples of 20 subgingival periopathogenic bacterial species were analysed using checkerboard dna-dna hybridization. blood samples (paxgeneblood), serum, gingval crevicular fluid were also collected at the three timepoints.

Eligibility criteria:
inclusion criteria: * healthy subjects * age 35-75 years * diagnosed with chronic periodontitis * at least four non-adjacent teeth with proximal sites with a pd ≥6 mm and clinical attachment loss ≥5 mm with bop and no radiographic signs of apical pathology. * either smokers (\>10 cigarettes per day for at least 5 years) or non-smokers (never smoked or not within the last 5 years). exclusion criteria: * subjects who presented with any current medical condition or used medications known to affect periodontal healing * incorrectly reported smoking status * use of antibiotics within 6 months of the study * received subgingival scaling within 6 months of the study
cognitive and mood assessment data in major depressive disorder using digital wearable technology

Conditions: Major Depressive Disorder

Summary: the purpose of this study was to evaluate the feasibility and compliance with a novel method for assessing mood and cognition in participants with major depressive disorder (mdd).

the novel method being tested in this study for assessing mood and cognition in participants with mdd was wearable technology. this study looked at the correlation of mood and cognition outcomes on wearable technology with traditional objective neuropsychological cognitive function tests and self-reported mood outcomes. the study enrolled approximately 30 patients. participants were provided with a watch on which brief cognitive and mood tests were evaluated daily up to 6 weeks. all participants prompted to complete cognitive and mood assessments on 3 occasions across the day. two occasions (morning and afternoon) comprised assessment of cognition, and the final assessment in the evening constituted a review of the day focusing on self-reported depressed mood. this single-center trial was conducted in united kingdom. the overall time to participate in this study was 6 weeks. participants took part up to 5 study visits (1 in-person on-site visit, 3 web-based and 1 at home visit) assessing performance on traditional objective neuropsychological cognitive function tests and self-reported measures of depression symptom severity and social function.

Eligibility criteria:
inclusion criteria: 1. has mdd as the primary psychiatric diagnosis. 2. has been treated previously with at least 1 antidepressant (monotherapy). 3. has scores on participant health questionnaire-9 items (phq-9) ≥5 and phq-9 ≤15 at screening exclusion criteria: 1. has a significant risk of suicide according to the investigator's clinical judgment or has made an actual suicide attempt in the previous 6 months prior to screening. 2. has a history of only responding to either combination or augmentation therapy in the current episode and has had been treated for more than a year without any period of remission. 3. has 1 or more of the following: 1. current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in diagnostic and statistical manual of mental disorders, 5th edition (dsm-5). 2. current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine). 3. neurodegenerative disorder (alzheimer disease, parkinson disease, multiple sclerosis, huntington disease, etc).

Keywords: drug therapy
therapy management with nab-paclitaxel in daily routine

Conditions: Metastatic Breast Cancer

Summary: despite treatment improvements in breast cancer, a large number of patients still progress to the metastatic stage. metastatic breast cancer patients have an extremely unfavorable prognosis. not only efficacy, but also quality of life are in the focus when planning a therapy or therapy sequence for metastatic breast cancer patients. therapy options include anti-hormonal therapy, antibody therapies, other targeted therapies and chemotherapies. one of the most effective chemotherapies in the adjuadjuvant and metastatic setting is paclitaxel. however drug handling and its side effects can compromise patients quality of life and can have an impact on the pharmacokinetics of the drug. in metastatic breast cancer patients increasing therapy efficacy and reduction of side effect frequency are considered to be advancements of therapy. one of these advancements is the development of a cremophor free and albumin bound paclitaxel, nab-paclitaxel (abraxane), which is thought to have a better efficacy and reduced toxicity profile. nab-paclitaxel is approved for the treatment of metastatic breast cancer after a failure of first-line therapy and when antracyclines are not indicated. the seraphina study aims to investigate in the use of nab-paclitaxel in daily routine and the frequency and perception of side effects. as a non-interventional study, the seraphina study will assess the patient characteristics and describe the patient cohort, in which nab-paclitaxel is given. this includes age distribution and characteristics documented by the patients themselves.


Eligibility criteria:
inclusion criteria: * patients with metastatic breast cancer in which a therapy with nab-paclitaxel was indicated by the treating physician * treatment of nab-paclitaxel must either have not been started yet, or first application of nab-paclitaxel was not prior to 21 days before study entry * female patients, age ≥18 years * invasive breast cancer (irrespective of status of bc, e.g. tnm, receptor status etc.) * metastatic or locally advanced, inoperable disease proven by clinical measures (i.e. standard imaging) * patients scheduled for nab-paclitaxel treatment in daily routine before screening * patients, who are able and willing to sign the informed consent form exclusion criteria: * patient is currently enrolled, or will enroll in an interventional clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study
fluoresence image guided surgery with a vegf-targeted tracer in soft-tissue sarcomas in humans approach with bevacizumab-irdye 800cw

Conditions: Soft Tissue Sarcoma

Summary: there is a need for better visualization of resection margins during surgery for soft tissue sarcoma. optical molecular imaging of soft tissue sarcoma associated biomarkers is a promising technique to accommodate this need. the biomarker vascular endothelial growth factor (vegf-a) is overexpressed in soft tissue sarcoma versus normal tissue and has proven to be a valid target for molecular imaging. vegf-a can be targeted by the monoclonal antibody bevacizumab. monoclonal antibodies can be labeled by the near-infrared (nir) fluorescent dye irdye800cw (800cw). the investigators hypothesize that bevacizumab-800cw accumulates in vegf expressing cancer, enabling soft tissue sarcoma visualization using a nir intraoperative camera system. in this pilot intervention study the investigators will determine the optimal dosage of bevacizumab-800cw (10, 25 or 50mg) to detect soft tissue sarcoma intraoperatively.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * patients with soft tissue sarcoma who are scheduled to undergo surgical intervention with curative intent * world health organization (who) performance score 0-2. * signed written informed consent exclusion criteria: * medical or psychiatric conditions that compromise the patient's ability to give informed consent. * other invasive malignancy * pregnant or lactating women. documentation of a negative pregnancy test must be available for woman of childbearing potential. woman of childbearing potential are pre- menopausal women with intact reproductive organs and women less than two years after menopause. * history of infusion reactions to bevacizumab or other monoclonal antibody therapies. * inadequately controlled hypertension with or without current antihypertensive medications * within 6 months prior to inclusion: myocardial infarction, transient ischemic attack, cerebral vascular accident, pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris.
pharmacokinetic comparison of advate rahf-pfm with recombinate rahf in patients with severe hemophilia a

Conditions: Hemophilia A

Summary: the purpose of this study is to compare the pharmacokinetic parameters and safety of advate rahf-pfm versus recombinate rahf in well described previously treated patients with severe hemophilia a (factor viii level \< 1%).


Eligibility criteria:
inclusion criteria: * signed informed consent obtained from participant or legally authorized representative * 15-60 years old * factor viii level \< 1% as documented by previously measured factor viii and genotyping * previously treated with factor viii concentrate(s) for a minimum of at least 150 exposure days (as documented by the study site investigator) prior to study entry * observed decrease of efficacy by subject and/or treating physician after being switched from recombinate rahf to advate rahf-pfm exclusion criteria: * the participant has a detectable factor viii inhibitor at screening, with a titer \>= 0.4 bethesda unit (bu) (nijmegen modification of the bethesda assay) measured at the local and the central laboratory * the participant has a known hypersensitivity to mouse or hamster proteins * the participant is participating in another investigational drug study within 30 days prior to screening * the participant is identified by the investigator as being unable or unwilling to cooperate with study procedures
safety and tolerability of liraglutide in subjects with impaired kidney function and in subjects with normal kidney function

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in oceania. the aim of this trial is to assess whether dose adjustment is required for patients with renal impairment by investigating the pharmacokinetics of liraglutide in subjects with various degrees of renal impairment.


Eligibility criteria:
inclusion criteria: * subjects meeting the pre-defined gfr (glomerular filtration rate) criteria (estimated by the cockcroft and gault formula) for any of the renal function groups * body mass index (bmi) maximum 40 kg/m\^2 exclusion criteria: * known or suspected allergy to trial product(s) or related products * renal transplanted patients * haemodialysis patients * cardiac problems * uncontrolled treated/untreated hypertension * history of alcoholism or drug abuse during the last 12 months * smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products * habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator * excessive consumption of food deviating from a normal diet as judged by the investigator
evaluation of the effects of neuromuscular electrical stimulation and mirror therapy in hemiplegia rehabilitation

Conditions: Hemiplegia; Upper Extremity Dysfunction

Summary: in this study, it was aimed to evaluate whether or not nmes in front of the mirror brings an additional benefit to mirror therapy alone or nmes alone on upper extremity motor and functional development, spasticity, anxiety, depression, cognitive function and activities of daily living, and neuropathic pain.

cerebrovascular diseases are the general name given to clinical neurological pictures that occur as a result of pathological changes in the blood vessels of the primary lesion and / or in the properties of the blood passing through them. many complications develop in the acute and chronic periods in patients with stroke, and the rate of complication development has been reported to vary between 40-96% in different studies. the aim of hemiplegic upper extremity rehabilitation is to prevent complications and improve lost motor-sensory control. upper limb rehabilitation is less successful than lower limb rehabilitation because the upper limb is more functional and more complex. for muscle reeducation, nmes is used to strengthen inhibited muscle groups, facilitate voluntary isolated muscle contraction, prevent muscle atrophy, increase metabolism and enzyme activity, change the contractile properties of the muscle, maintain or increase the normal range of motion of the joint, develop voluntary movement and functional gains. nmes has been used in hemiplegia rehabilitation since 1960 for the purpose of functional retraining of muscles. the purpose of this treatment is to enable the muscles with impaired neural function of the electrical current to perform a functional and useful movement. applications in front of the mirror are thought to trigger the neuronal connections in the motor cortex associated with the imagined movement. findings obtained from studies with functional magnetic resonance support this theory. compared to conventional pr, applications in front of the mirror are thought to have more and longer-lasting effects.

Eligibility criteria:
inclusion criteria: * subacute hemiplegia * patients who can communicate well, are motivated enough and are willing to participate in the study * patients' medical conditions are stable * initiation of voluntary extension movement in the wrist (lower limit) exclusion criteria: * the presence of more than one previous cerebrovascular disease (except transient ischemic attack). * presence of flaccid hemiplegia. * presence of a previous neurological disease causing a decrease in strength in the affected extremity. * presence of deformity due to a previous fracture, inflammatory arthropathy, etc. in the affected extremity. * presence of more than grade 3 spasticity in upper extremity according to modified ashworth scale * use of cardiac pace maker * presence of fatal cardiac arrhythmia * presence of seizure history within 2 years.

Keywords: hemiplegia mirror theraphy nmes
validation of dna methylation biomarkers for oral cancer detection-follow up study

Conditions: Oral Cancer

Summary: this is a follow up study which aims to evaluate the correlation between several methylated genes (potential biomarkers) and oral cancers. a prospective case control trial is designed with sample size of at least 300 cases with estimated 200 subjects with precancerous lesion or oral cancer, and 100 subjects with normal oral mucosa. this study is approved by the national taiwan university hospital research ethics committee. after signing the informed consent, all subjects will receive an intraoral examination and followed by epithelial cells collection with oral swab. the gdna will be extracted from the oral swab collected cells and followed by bisulfite conversion procedures. subsequently, bisulfite converted dna will be subjected to methylated gene detection by real-time pcr. the methylation index (clinical sensitivity and specificity) of oral cancer related genes will be evaluated. for diagnosis confirmation, photos and biopsy specimens will be taken upon observation of abnormal lesion.


Eligibility criteria:
inclusion criteria: * subject with age over 20. * subjects with oral mucosal findings (normal, oral mucosal lichen planus, precancerous lesion, and oral cancer) or subjects who have involved in the previous study (nct01945697). * subjects agrees to sign the informed consent form. exclusion criteria: * pregnant woman. * subject disagrees to sign the informed consent form.
tumor growth rate (tgr) predicts clinical outcomes for advanced non-small cell lung cancer undergoing immunotherapy.

Conditions: Non-Small Cell Lung Cancer

Summary: we hypothesized that tgr could serve as an early predictor of outcomes for ansclc patients undergoing immune checkpoint inhibitors (icis). a retrospective analysis was conducted to investigate the association of tgr with response and long-term survival of ansclc patients undergoing ici therapy.

tumor growth rate (tgr) signifies percentage change in tumor size per month (%/m). electronic medical records were retrospectively reviewed for all histologically confirmed ansclc patients undergoing anti-pd-1/pd-l1 therapy at sun yat-sen university cancer center (sysucc) between august 2016 and june 2018. all response and outcome evaluation were determined as per recist 1.1 by two senior radiologists blinded to patients'information. discrepancy was solved by consensus. x-tile software was used to determine cut-off values that maximumly differentiate overall survival (os). log-rank tests and cox regression models were performed for survival analysis. the predictive value of tgr for clinical outcomes in ici-treated ansclc patients was validated in two external cohorts, recruited form guangdong province traditional chinese medical hospital and shanghai chest hospital.

Eligibility criteria:
inclusion criteria: * histologically confirmed ansclc patients * having received anti-pd-1/pd-l1 therapy * must have two consecutive computed tomography (ct) scans upon early treatment (from baseline to the first imaging evaluation) exclusion criteria: * lacking available computed tomography (ct) evaluation at any of two time points-baseline and the first evaluation * without measurable lesions at baseline ct scan * having received local anticancer therapy during ici treatment, for example, radiotherapy and radiofrequency ablation

Keywords: tumor growth rate nsclc immunotherapy
ultrasound to predict steal-syndrome after arteriovenous-fistula creation (upsac - trial)

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to analyze and identify pre-, intra-, and post- operative parameters that predict steal-syndrome with distal malperfusion after arterio-venous fistulas (avf) as primary endpoint. secondary endpoints are pre-, intra-, and post- operative parameters that predict patency and fistula maturation.

this is a prospective study where the research team will acquire data from the patients after they have signed the informed consent form. data will be collected before, during and after the arterio-venous fistula(avf)placement, and during follow-up at predefined time intervals:pre-operative, intra-operative, post-operative, 5-10 days, 4-6 weeks, 6 months, and 1 year. these parameters include digital brachial index (dbi) (assessed by doppler derived brachial artery blood pressure/ photoplethysmographically derived finger blood pressure), flow and pulsatility measurements (derived by duplex ultrasound and pulse volume recording). assessment of flow and pulsatility will be performed in the artery proximal and distal to the avf, as well as in the venous outflow. in addition, demographic parameters and patient comorbidities will be acquired and procedure specific parameters (e.g. location of the fistula) will be documented. during each follow up, clinical evaluation for steal-syndrome will be conducted. steal-syndrome was defined according to the guidelines of the society of vascular surgery (svs): asymptomatic (pulse deficits, doppler signal attenuation, and distal flow reversal) mild ischemia: slight coldness and numbness that occurs only during dialysis, may be self-limited, and may resosolve without treatment, and severe ischemia: can be permanent and may be associated with constant pain, severe numbness, digital cyanosis or gangrene, finger contracture, or amputation of a digit hand or forearm. the necessity for and type of re-intervention at the avf will be documented. acquisition of data will in no way change the standard of care used in these patients / operations. data analysis will be performed after enrolment of 100, 250 and 500 patients.

Eligibility criteria:
inclusion criteria: * patients 18 years of age * autogenous, brachio-cephalic, brachio-basilic or brachio-brachial arterio- venous fistula creation for hemodialysis * general preoperative requirements for this surgery passed * patients willing to adhere to the follow-up * patients able to understand and provide informed consent exclusion criteria: * less than 18 years of age * patient is unable or unwilling to provide consent * prosthetic graft creation * creation of a radio-cephalic av-fistula other than described in the inclusion criteria

Keywords: chronic kidney disease arteriovenous fistula
evaluation of cognitive status, kinesiophobia, physical activity level, and functional performance in coronary intensive care

Conditions: Heart Diseases

Summary: the aim of our study is to evaluate cognitive status, kinesiophobia, physical activity level, and functional performance in coronary intensive care.

this study will be performed on patients who are hospitalized in the coronary intensive care unit, who can take simple commands, and whose condition is physiologically stable.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the research * being under surveillance in the coronary intensive care unit exclusion criteria: * presence of neurological disease that may affect the cognitive status * not being clinically stable * not to cooperate

Keywords: intensive care coronary artery disease kinesiophobia physical activity level